NL-OMON34322已完成4 期
An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery - BI trial no.: 1160.86
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) patients scheduled for primary unilateral elective total knee or hip replacement, male or
- •female being 18 years or older
- •2) moderate renal impairment (creatine clearance 30 - 50 ml/min)
- •3) written informed consent
- •4) caucasian patients
排除标准
- •1) Patients weighing less than 40 kg
- •2) patients requiring chronic treatment with anticoagulants
- •3) patients who in the investigators judgement are perceived as having an excessive risk of
- •4) recent unstable cardiovasculair disease
- •5) ongoing treatment for VTE;See page 19 - 21 of the study protocol for all exclusion criteria
研究者
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